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Phase 2 Trial of Anti-TL1A Monoclonal Antibody Tulisokibart for Ulcerative Colitis.
Sands, Bruce E; Feagan, Brian G; Peyrin-Biroulet, Laurent; Danese, Silvio; Rubin, David T; Laurent, Olivier; Luo, Allison; Nguyen, Deanna D; Lu, Jiandong; Yen, Mark; Leszczyszyn, Jaroslaw; Kempinski, Radoslaw; McGovern, Dermot P B; Ma, Christopher; Ritter, Timothy E; Targan, Stephan.
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  • Sands BE; From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Departments of Medicine, Epidemiology, and Biostatistics, Western University, London, ON (B.G.F.), and the Division of Gastroenterology and Hepatology, Departments of Medicine
  • Feagan BG; From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Departments of Medicine, Epidemiology, and Biostatistics, Western University, London, ON (B.G.F.), and the Division of Gastroenterology and Hepatology, Departments of Medicine
  • Peyrin-Biroulet L; From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Departments of Medicine, Epidemiology, and Biostatistics, Western University, London, ON (B.G.F.), and the Division of Gastroenterology and Hepatology, Departments of Medicine
  • Danese S; From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Departments of Medicine, Epidemiology, and Biostatistics, Western University, London, ON (B.G.F.), and the Division of Gastroenterology and Hepatology, Departments of Medicine
  • Rubin DT; From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Departments of Medicine, Epidemiology, and Biostatistics, Western University, London, ON (B.G.F.), and the Division of Gastroenterology and Hepatology, Departments of Medicine
  • Laurent O; From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Departments of Medicine, Epidemiology, and Biostatistics, Western University, London, ON (B.G.F.), and the Division of Gastroenterology and Hepatology, Departments of Medicine
  • Luo A; From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Departments of Medicine, Epidemiology, and Biostatistics, Western University, London, ON (B.G.F.), and the Division of Gastroenterology and Hepatology, Departments of Medicine
  • Nguyen DD; From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Departments of Medicine, Epidemiology, and Biostatistics, Western University, London, ON (B.G.F.), and the Division of Gastroenterology and Hepatology, Departments of Medicine
  • Lu J; From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Departments of Medicine, Epidemiology, and Biostatistics, Western University, London, ON (B.G.F.), and the Division of Gastroenterology and Hepatology, Departments of Medicine
  • Yen M; From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Departments of Medicine, Epidemiology, and Biostatistics, Western University, London, ON (B.G.F.), and the Division of Gastroenterology and Hepatology, Departments of Medicine
  • Leszczyszyn J; From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Departments of Medicine, Epidemiology, and Biostatistics, Western University, London, ON (B.G.F.), and the Division of Gastroenterology and Hepatology, Departments of Medicine
  • Kempinski R; From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Departments of Medicine, Epidemiology, and Biostatistics, Western University, London, ON (B.G.F.), and the Division of Gastroenterology and Hepatology, Departments of Medicine
  • McGovern DPB; From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Departments of Medicine, Epidemiology, and Biostatistics, Western University, London, ON (B.G.F.), and the Division of Gastroenterology and Hepatology, Departments of Medicine
  • Ma C; From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Departments of Medicine, Epidemiology, and Biostatistics, Western University, London, ON (B.G.F.), and the Division of Gastroenterology and Hepatology, Departments of Medicine
  • Ritter TE; From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Departments of Medicine, Epidemiology, and Biostatistics, Western University, London, ON (B.G.F.), and the Division of Gastroenterology and Hepatology, Departments of Medicine
  • Targan S; From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Departments of Medicine, Epidemiology, and Biostatistics, Western University, London, ON (B.G.F.), and the Division of Gastroenterology and Hepatology, Departments of Medicine
N Engl J Med ; 391(12): 1119-1129, 2024 Sep 26.
Article en En | MEDLINE | ID: mdl-39321363
ABSTRACT

BACKGROUND:

Tulisokibart is a tumor necrosis factor-like cytokine 1A (TL1A) monoclonal antibody in development for the treatment of moderately to severely active ulcerative colitis. A genetic-based diagnostic test was designed to identify patients with an increased likelihood of response.

METHODS:

We randomly assigned patients with glucocorticoid dependence or failure of conventional or advanced therapies for ulcerative colitis to receive intravenous tulisokibart (1000 mg on day 1 and 500 mg at weeks 2, 6, and 10) or placebo. Cohort 1 included patients regardless of status with respect to the test for likelihood of response. Cohort 2 included only patients with a positive test for likelihood of response. The primary analysis was performed in cohort 1; the primary end point was clinical remission at week 12. Patients with a positive test for likelihood of response from cohorts 1 and 2 were combined in prespecified analyses.

RESULTS:

In cohort 1, a total of 135 patients underwent randomization. A significantly higher percentage of patients who received tulisokibart had clinical remission than those who received placebo (26% vs. 1%; difference, 25 percentage points; 95% confidence interval [CI], 14 to 37; P<0.001). In cohort 2, a total of 43 patients underwent randomization. A total of 75 patients with a positive test for likelihood of response underwent randomization across both cohorts. Among patients with a positive test for likelihood of response (cohorts 1 and 2 combined), clinical remission occurred in a higher percentage of patients who received tulisokibart than in those who received placebo (32% vs. 11%; difference, 21 percentage points; 95% CI, 2 to 38; P = 0.02). Among all the enrolled patients, the incidence of adverse events was similar in the tulisokibart and placebo groups; most adverse events were mild to moderate in severity.

CONCLUSIONS:

In this short-term trial, tulisokibart was more effective than placebo in inducing clinical remission in patients with moderately to severely active ulcerative colitis. (Funded by Prometheus Biosciences, a subsidiary of Merck; ARTEMIS-UC ClinicalTrials.gov number, NCT04996797.).
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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Inducción de Remisión / Colitis Ulcerosa / Miembro 15 de la Superfamilia de Ligandos de Factores de Necrosis Tumoral / Anticuerpos Monoclonales Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: N Engl J Med Año: 2024 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Base de datos: MEDLINE Asunto principal: Inducción de Remisión / Colitis Ulcerosa / Miembro 15 de la Superfamilia de Ligandos de Factores de Necrosis Tumoral / Anticuerpos Monoclonales Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: N Engl J Med Año: 2024 Tipo del documento: Article